RCT comparing the rates of severe hypoglycaemia (coma/seizure) in patients using CSII versus Sensor Augmented Pump therapy with the Low Glucose Suspend feature ON over a 6 month period in 95 children and adults with impaired hypo awareness.

Result:

Significant reduction in the number of severe hypoglycaemic events from 21.9 to 0.0 events/100pt-yrs (low glucose suspend-On group)vs. 24.8 to 26.7 events/100 pt-yrs in the CSII group (p=0.017)

Significant reduction in exposure to glucose values below 70mg/dl and 60mg/dl in the low glucose suspend group compared to control (p=0.006 and p=0.009 respectively)

Reduced fear of hypoglycaemia was shown in the low glucose suspend group

Six month single-crossover continuation phase of STAR 3 with 420 patients to determine the effects of crossing over from optimised multiple daily injections to Sensor-Augmented Pump therapy for six months and determine the effects of 10 months use of sensor augmented pump therapy.